Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth
2013-11-22
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Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth
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2013-11-22
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Hodges, James S.
hodge003@umn.edu
hodge003@umn.edu
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Experimental Data
Abstract
The OPT Study was a multi-center randomized, single-blind (examiners) controlled clinical trial testing whether mechanical periodontal therapy (scaling and planing) in pregnant women at risk for premature birth reduced the extent or severity of premature birth. OPT found that periodontal therapy does not reduce the number or timing of premature births.
Data include birth outcomes (including gestational age, birthweight, presence of congenital anomalies, and 1 and 5 minute APGAR scores), baseline characteristics (including previous pregnancy outcomes), periodontal therapy and essential dental care delivered as part of the study, maternal conditions during pregnancy, and the following items for three visits between the end of the first trimester and delivery: clinical periodontal measurements (pocket depth, attachment loss, and bleeding on probing at 6 sites per tooth; site-specific data and several common person-level summaries), medications, dental plaque levels of 8 bacterial species, levels of serum antibodies for the same 8 bacterial species, and serum levels of 8 inflammatory markers or mediators. The OPT Study's Manual of Procedures (Version 1) is available as part of this package. Version changes during the course of the study were rare and affected very few data items (mostly the data describing study periodontal therapy).
The OPT Study team published the main paper in 2006 in the New England Journal of Medicine and has published 8 secondary papers.
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The collected data are documented in the Data Dictionary and the Manual of Practice files. Citations using the data are included in a text file.
Referenced by
Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. (2006). Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2; 355 (18). p1885-94.
http://dx.doi.org/10.1056/NEJMoa062249
http://dx.doi.org/10.1056/NEJMoa062249
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The data in these files were collected during the OPT Study funded by the National Institute of Dental and Craniofacial Research, grant number DE014338. The ClinicalTrials.gov number is NCT00066131.
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Hodges, James S; Michalowicz, Bryan S. (2013). Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth. Retrieved from the Data Repository for the University of Minnesota (DRUM), http://dx.doi.org/10.13020/D6KW2D.
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OPT_Study_Documentation_Data_Dictionary.pdf
Study Documentation and Data Dictionary
(71.59 KB)
OPT_Study_Manual_of_Procedures_Version_1.pdf
Manual of Procedures
(3.23 MB)
citations.txt
Citations to Related Publications
(2.44 KB)
OPT_Study_DataAccess.txt
Access to study data
(393 B)
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